BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER SKIN GRAFT MESHER

    MDR report key: 2801585 · Received October 18, 2012

    Report

    Report Number
    1526350-2012-00258
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    FZW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND EVALUATION. THE SERVICE RECORD INDICATES THAT THE DEVICE IS 8 YEARS OLD AND WAS LAST RETURNED TO THE MANUFACTURER FOR REPAIR ON (B)(4) 2011. INVESTIGATION OF THE DEVICE VERIFIED THE COMB TO BE DAMAGED. IT WAS ALSO OBSERVED THE SCREW ABOVE THE LOCKING PIN WAS MISSING. IMPROPER PLACEMENT OF THE CUTTER BY THE CUSTOMER AND MOST LIKELY CAUSED THE DAMAGE TO THE DEVICE. CUSTOMER'S CUTTERS WERE NOT SENT IN FOR EVALUATION, AND MAY DISPLAY DAMAGE AS WELL. THE DEVICE WAS SERVICED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ZIMMER SKIN GRAFT MESHER HAD A BENT COMB. ADDITIONAL CLINICAL FOLLOW UP WITH THE HOSPITAL INDICATED THAT THE CUTTING WHEEL WAS PLACED IN THE HOLDER, THE WHEEL DID NOT MOVE WHEN THE HANDLE WAS TURNED. THE REPORTED EVENT WAS STATED TO HAVE OCCURRED PRIOR TO PATIENT USE, THE DEVICE WAS NOT USED FOR THE PROCEDURE, AND THE PROCEDURE START WAS NOT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER SKIN GRAFT MESHER ZIMMER SKIN GRAFT MESHER FZW ZIMMER SURGICAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1